To view the multimedia assets associated with this press release, please click: 2026世界杯直播赛程 http://www.multivu.com/players/English/7414052-amgen-repatha/.
The EC approved Repatha for:
The effect of Repatha on cardiovascular morbidity 观看比赛直播 and 世界杯直播频道 mortality has 观看比赛直播 not yet been determined.
More than 60 percent of high-risk patients in
世界杯直播频道 2026世界杯直播赛程
"We are proud that 观看比赛直播 our cholesterol-lowering medication, Repatha, is the first PCSK9 inhibitor to be approved by any regulatory agency in the world," said
世界杯直播频道
One high-risk 世界杯直播频道 patient group includes those with familial hypercholesterolemia 观看比赛直播 (FH), an inherited condition caused by genetic mutations 世界杯直播频道 which lead to high levels 世界杯直播频道 of LDL-C at an early age.8 It is 世界杯直播频道 FIFA 2026开球时间 观看比赛直播 2026世界杯直播赛程 FIFA 2026开球时间 2026世界杯直播赛程 世界杯直播频道 estimated that less than one percent 世界杯直播频道 of people with FH (heterozygous and homozygous forms) in most countries are diagnosed.9
"Many patients who are taking cholesterol-lowering therapies, including those with 2026世界杯直播赛程 familial hypercholesterolemia, still struggle to control their FIFA 2026开球时间 LDL cholesterol levels," said
世界杯直播频道 观看比赛直播
Approval from the EC grants a centralized marketing authorization with unified labeling in the 28 countries that FIFA 2026开球时间 are members of the EU.
世界杯直播频道 世界杯直播频道
Data show Repatha has demonstrated substantial and consistent reductions in LDL-C levels with supporting beneficial changes in other lipid parameters in approximately 6,000 patients with primary hyperlipidemia FIFA 2026开球时间 FIFA 2026开球时间 世界杯直播频道 and mixed dyslipidemia, including more than 4,500 patients with high cholesterol in 10 Phase 3 trials.10 In these studies, Repatha significantly 世界杯直播频道 reduced LDL-C by approximately 55 percent to FIFA 2026开球时间 FIFA 2026开球时间 世界杯直播频道 75 percent compared with placebo,11-14 and by approximately 35 percent to 世界杯直播频道 观看比赛直播 45 percent compared 观看比赛直播 with ezetimibe.11,12,14 In patients FIFA 2026开球时间 with homozygous FH, Repatha significantly reduced LDL-C by approximately 15 percent to 30 percent compared with placebo.15 Reduction of LDL-C was maintained with long-term treatment.16
The adverse event profile for Repatha was comparable overall to that 世界杯直播频道 of the control groups.11-17 The most common adverse 观看比赛直播 reactions that 世界杯直播频道 occurred in greater than or equal 2026世界杯直播赛程 to 2 percent of the Repatha
FIFA 2026开球时间 FIFA 2026开球时间 世界杯直播频道 group, and more frequently than in the control group, were nasopharyngitis, upper respiratory tract infection, back pain, arthralgia, influenza and FIFA 2026开球时间 nausea. Please consult the Summary of Product Characteristics
FIFA 2026开球时间 2026世界杯直播赛程 FIFA 2026开球时间 (
FIFA 2026开球时间 FIFA 2026开球时间
Repatha is for subcutaneous injection into the abdomen, thigh or upper 世界杯直播频道 arm 观看比赛直播 region. Injection sites should be rotated and injections should not be given into areas where the skin is tender, bruised, red or 世界杯直播频道 hard. Repatha must not be administered intravenously or intramuscularly. Before starting treatment with FIFA 2026开球时间 Repatha, secondary causes (non-genetic) of excess cholesterol 2026世界杯直播赛程 and abnormal fat levels in blood 观看比赛直播 世界杯直播频道 should be excluded. The medicine can only be obtained with a prescription.
The recommended dose for adults FIFA 2026开球时间 with primary disease is either 140 mg every two weeks or 420 mg (the contents of three pre-filled syringes) 世界杯直播频道 once a FIFA 2026开球时间 month; both doses 观看比赛直播 are clinically equivalent. For adults FIFA 2026开球时间 or children older than 12 years with homozygous FH, the initial recommended dose is 世界杯直播频道 420 观看比赛直播 mg once a month. If a response is not achieved after 12 weeks of treatment, the dose can be increased up to 观看比赛直播 420 观看比赛直播 mg every 世界杯直播频道 two weeks. For more information, see the package leaflet.
About RepathaTM (evolocumab)
Repatha™ (evolocumab) is a human monoclonal antibody 世界杯直播频道 that inhibits proprotein convertase subtilisin/kexin 世界杯直播频道 type 9 (PCSK9).1 PCSK9 is a protein that targets LDL receptors
世界杯直播频道 FIFA 2026开球时间 世界杯直播频道 for degradation and thereby reduces the liver's ability to remove LDL-C, or "bad" cholesterol, from the blood.18 Repatha, developed by
世界杯直播频道 FIFA 2026开球时间 世界杯直播频道
Important FIFA 2026开球时间 EU Product 世界杯直播频道 Information
Hypercholesterolemia and mixed dyslipidemia
Repatha is indicated in adults with primary hypercholesterolemia (heterozygous familial and non-familial) or mixed dyslipidemia, as an adjunct to diet:
Homozygous familial hypercholesterolemia
Repatha is indicated in adults and adolescents aged 12 years and over with homozygous familial hypercholesterolemia in combination with 世界杯直播频道 other lipid-lowering therapies.
The effect of Repatha 世界杯直播频道 on cardiovascular morbidity and mortality has not yet been determined.
Important Safety Information
▼ This medicinal product is subject to additional monitoring. This will allow quick identification of new FIFA 2026开球时间 safety information. Healthcare professionals FIFA 2026开球时间 are asked 世界杯直播频道 to report any suspected adverse reactions. FIFA 2026开球时间 FIFA 2026开球时间 世界杯直播频道 世界杯直播频道
Contraindications: Hypersensitivity to 世界杯直播频道 the active substance or to any of the 世界杯直播频道 excipients.
Special Warnings and Precautions: 世界杯直播频道 Renal impairment: Patients with severe 世界杯直播频道 2026世界杯直播赛程 renal impairment (defined as eGFR < 30 mL/min/1.73 m2) have not been studied. Repatha should be used with 世界杯直播频道 观看比赛直播 2026世界杯直播赛程 世界杯直播频道 世界杯直播频道 caution in patients with FIFA 2026开球时间 severe renal impairment. Hepatic impairment: In patients 2026世界杯直播赛程 with moderate hepatic impairment, a reduction in total evolocumab exposure FIFA 2026开球时间 was observed that may lead to a reduced FIFA 2026开球时间 effect on 世界杯直播频道 LDL‑C reduction. Therefore, close monitoring may be warranted FIFA 2026开球时间 in 观看比赛直播 these patients. Patients with severe hepatic impairment (Child-Pugh C) have not been studied. Repatha should be used with caution 2026世界杯直播赛程 FIFA 2026开球时间 观看比赛直播 in patients with severe hepatic impairment. FIFA 2026开球时间 Dry natural rubber: The needle cover of the glass pre-filled syringe and of the pre-filled pen is made from 世界杯直播频道 dry natural rubber (a derivative of latex), 世界杯直播频道 世界杯直播频道 which may cause allergic FIFA 2026开球时间 reactions. Sodium content: Repatha contains less than 1 mmol sodium (23 mg) per dose, i.e. it is essentially 'sodium-free'.
Interactions: No 观看比赛直播 formal drug-drug interaction studies have been conducted for Repatha. No studies on pharmacokinetic and pharmacodynamics interaction between Repatha and lipid-lowering drugs other FIFA 2026开球时间 2026世界杯直播赛程 观看比赛直播 2026世界杯直播赛程 世界杯直播频道 FIFA 2026开球时间 than statins and ezetimibe have been conducted.
Fertility, Pregnancy and Lactation: There FIFA 2026开球时间 are no or limited amount of data from the use of Repatha in pregnant women. Repatha should not be used during pregnancy unless the clinical condition of the 世界杯直播频道 观看比赛直播 FIFA 2026开球时间 世界杯直播频道 woman requires treatment with evolocumab. It is unknown whether evolocumab is excreted in human milk. A risk to breastfed newborns/infants cannot be excluded. No data on the effect of evolocumab on human 世界杯直播频道 fertility are available.
Undesirable Effects: The 2026世界杯直播赛程 following common (> 1/100 to < 1/10) adverse reactions have been reported in pivotal, 观看比赛直播 controlled clinical studies: influenza, nasopharyngitis, upper respiratory
2026世界杯直播赛程 世界杯直播频道 tract infection, rash, FIFA 2026开球时间 世界杯直播频道 nausea, back pain, arthralgia, injection site reactions. Please consult the
FIFA 2026开球时间 FIFA 2026开球时间 观看比赛直播 2026世界杯直播赛程 2026世界杯直播赛程
Pharmaceutical 世界杯直播频道 Precautions: Store in a refrigerator (2 degrees C – 8 degrees C). Do not freeze. FIFA 2026开球时间 Keep the pre-filled 观看比赛直播 syringe or the pre-filled pen FIFA 2026开球时间 in the 观看比赛直播 original carton FIFA 2026开球时间 in order 观看比赛直播 to protect from light. FIFA 2026开球时间 观看比赛直播 FIFA 2026开球时间 If removed from the refrigerator, Repatha may be stored at room temperature (up to 25 degrees C) FIFA 2026开球时间 in the 2026世界杯直播赛程 original carton and must be used within 1 week.
About Amgen Cardiovascular
Building on more than three decades of experience in developing biotechnology medicines for patients with serious illnesses,
2026世界杯直播赛程 世界杯直播频道 2026世界杯直播赛程 FIFA 2026开球时间
About
For more information, visit http://www.amgen.com/ and follow us on www.twitter.com/amgen.
Forward-Looking Statements
This news release contains forward-looking statements that are based on management's current FIFA 2026开球时间 观看比赛直播 expectations and beliefs and are subject to a number of risks, uncertainties and assumptions that could cause
FIFA 2026开球时间 actual results to differ materially from those described. All statements, other 观看比赛直播 than 世界杯直播频道 statements of historical fact, are statements that could be deemed forward-looking 世界杯直播频道 statements, including FIFA 2026开球时间 estimates
of revenues, operating margins, capital expenditures, cash, other 2026世界杯直播赛程 financial metrics, expected legal, arbitration, political, regulatory or clinical results or practices, customer and prescriber patterns
2026世界杯直播赛程 or practices, reimbursement activities and outcomes and other such estimates and results. 观看比赛直播 Forward-looking statements 2026世界杯直播赛程 involve significant risks and uncertainties, including those discussed below and more
观看比赛直播 fully described in the
FIFA 2026开球时间 世界杯直播频道 FIFA 2026开球时间
No forward-looking statement can be guaranteed 世界杯直播频道 and 观看比赛直播 actual results may differ materially from those we project. Discovery or identification of new product candidates or development of new indications for 世界杯直播频道 existing products cannot be guaranteed and movement from concept to product is uncertain; consequently, there can be FIFA 2026开球时间 no 观看比赛直播 guarantee that any particular product candidate or development of a new FIFA 2026开球时间 indication 观看比赛直播 世界杯直播频道 观看比赛直播 FIFA 2026开球时间 for an existing product will be successful and become a commercial product. Further, preclinical results do not guarantee safe and effective FIFA 2026开球时间 performance of product candidates in humans. The complexity 2026世界杯直播赛程 观看比赛直播 of the human body cannot be perfectly, or sometimes, even adequately FIFA 2026开球时间 modeled by computer or cell culture systems or animal models. The length of time that it takes for us to complete clinical trials FIFA 2026开球时间 FIFA 2026开球时间 and obtain regulatory approval for 2026世界杯直播赛程 product marketing has in the past varied and we expect 世界杯直播频道 similar variability in the future. We develop product candidates internally and through licensing collaborations, FIFA 2026开球时间 partnerships FIFA 2026开球时间 and joint ventures. Product candidates that are derived from relationships may be subject to disputes between the parties or may prove to be not as effective or as safe as we may have believed 世界杯直播频道 世界杯直播频道 FIFA 2026开球时间 at the time of entering into such relationship. Also, we or others could identify safety, side effects or manufacturing problems with our products after they are on the market. Our business may be impacted 世界杯直播频道 by government investigations, litigation and products liability claims. We depend on third parties for a significant portion of FIFA 2026开球时间 our manufacturing capacity for the supply 世界杯直播频道 of certain of our current and FIFA 2026开球时间 世界杯直播频道 future products and limits on supply may constrain sales of certain of our current products and product candidate 观看比赛直播 development.
In addition, sales of our products are affected by the reimbursement policies imposed by third-party payors, including governments, private insurance plans and managed care providers and may be affected FIFA 2026开球时间 FIFA 2026开球时间 世界杯直播频道 by regulatory, clinical and guideline 世界杯直播频道 developments and 2026世界杯直播赛程 domestic and international trends toward managed care and healthcare cost containment as well as U.S. legislation affecting pharmaceutical 世界杯直播频道 pricing 世界杯直播频道 FIFA 2026开球时间 and reimbursement. Government and others' regulations and reimbursement policies may affect the development, usage and pricing of our products. In addition, we compete with other companies with respect FIFA 2026开球时间 世界杯直播频道 to some of our marketed products as well as for the discovery and development of new products. We believe that some of our newer products, product candidates or 2026世界杯直播赛程 new indications for existing products, FIFA 2026开球时间 FIFA 2026开球时间 may face competition when and as they are 世界杯直播频道 approved and marketed. Our products may compete against products that have lower prices, established reimbursement, superior performance, are 世界杯直播频道 easier to administer, or that are otherwise competitive with 2026世界杯直播赛程 our products. In addition, while we routinely obtain patents for our products and technology, the protection offered by our patents and patent applications may be challenged, invalidated or circumvented by our competitors and there can be no guarantee of our ability to obtain or maintain patent protection for our products or product candidates. We cannot guarantee 世界杯直播频道 世界杯直播频道 that we will be able to produce commercially successful products or maintain the commercial 观看比赛直播 2026世界杯直播赛程 success of our existing products. Our stock price may be affected by actual or perceived market opportunity, competitive position, and 观看比赛直播 success or failure of our products or product candidates. Further, the discovery of significant problems FIFA 2026开球时间 with 2026世界杯直播赛程 a product similar to one of 观看比赛直播 our products FIFA 2026开球时间 that implicate an entire 观看比赛直播 世界杯直播频道 世界杯直播频道 class of products could have a material adverse effect on sales of the affected products and FIFA 2026开球时间 on our business and results of operations. Our efforts to integrate the operations of companies we have acquired 世界杯直播频道 世界杯直播频道 FIFA 2026开球时间 世界杯直播频道 FIFA 2026开球时间 may not be successful. We may experience difficulties, delays or unexpected costs and not achieve anticipated benefits and savings 世界杯直播频道 from our recently announced restructuring plan. Our business performance 2026世界杯直播赛程 could affect 观看比赛直播 or limit the ability of our Board of Directors to declare a dividend or their ability to pay a dividend or repurchase our common stock.
The scientific information discussed in this news release related to our product candidates is specific to the
世界杯直播频道 2026世界杯直播赛程 FIFA 2026开球时间
CONTACT:
FIFA 2026开球时间 观看比赛直播
Amgen, Europe
References
1. Amgen Data on FIFA 2026开球时间 File, Investigator Brochure.
2.
观看比赛直播 FIFA 2026开球时间 2026世界杯直播赛程 世界杯直播频道 FIFA 2026开球时间 世界杯直播频道 FIFA 2026开球时间 FIFA 2026开球时间
3. Merck Manuals website. http://www.merckmanuals.com/professional/endocrine_and_metabolic_disorders/lipid_disorders/dyslipidemia.html.
FIFA 2026开球时间 Accessed
FIFA 2026开球时间
4.
2026世界杯直播赛程 世界杯直播频道 观看比赛直播 FIFA 2026开球时间
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观看比赛直播
6. Halcox JP, et al. Low Rates of Both Lipid-Lowering Therapy Use and Achievement of Low-Density Lipoprotein Cholesterol Targets in Individuals at High-Risk for 2026世界杯直播赛程 Cardiovascular Disease across
FIFA 2026开球时间 2026世界杯直播赛程
7. Leal J, et al. Economic Costs. In: Nichols M, et al. European Cardiovascular Disease Statistics 2012.
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世界杯直播频道 世界杯直播频道 FIFA 2026开球时间
9. Nordestgaard BG, Chapman MJ, Humphries 观看比赛直播 SE, et al. Familial Hypercholesterolaemia is Underdiagnosed and Undertreated in the General Population: Guidance FIFA 2026开球时间 for Clinicians to 世界杯直播频道 2026世界杯直播赛程 Prevent Coronary Heart Disease.
2026世界杯直播赛程 世界杯直播频道
10. Sabatine MS, 世界杯直播频道 Giugliano RP, Wiviott SD, et al. Efficacy and Safety 世界杯直播频道 of Evolocumab in Reducing FIFA 2026开球时间 Lipids and Cardiovascular Events. FIFA 2026开球时间 N Engl J Med. 2026世界杯直播赛程 2015;372:1500-1509.
11. Koren MJ, Lundqvist P, Bolognese M, et al. Anti-PCSK9 monotherapy for FIFA 2026开球时间 hypercholesterolemia: the MENDEL-2 FIFA 2026开球时间 randomized, controlled phase III clinical trial of evolocumab. J Am Coll Cardiol. 2014;63:2531-2540.
12. Robinson JG, 世界杯直播频道 Nedergaard BS, Rogers WJ, et al. Effect of evolocumab or ezetimibe added to moderate or high-intensity statin therapy on LDL-C lowering in patients with hypercholesterolemia. The LAPLACE-2 世界杯直播频道 FIFA 2026开球时间 世界杯直播频道 观看比赛直播 randomized clinical trial. JAMA. 2014;311:1870-1882.
13. Raal FJ, Stein EA, Dufour FIFA 2026开球时间 R, et al. PCSK9 inhibition with evolocumab (AMG 145) in heterozygous familial hypercholesterolaemia (RUTHERFORD-2): a randomised, double-blind, placebo-controlled trial. Lancet. FIFA 2026开球时间 FIFA 2026开球时间 2026世界杯直播赛程 2015;385:331-340.
14. 世界杯直播频道 Stroes E, Colquhoun D, Sullivan D, et al. Anti-PCSK9 antibody effectively lowers cholesterol in patients with statin intolerance: the GAUSS-2 randomized, placebo-controlled phase 3 clinical trial of FIFA 2026开球时间 FIFA 2026开球时间 evolocumab. J Am Coll Cardiol. 2014;63:2541-2548.
15. Raal 世界杯直播频道 FJ, Honarpour N, Blom DJ, et al. Inhibition of PCSK9 with evolocumab in homozygous familial hypercholesterolaemia (TESLA Part 世界杯直播频道 B): a randomised, double-blind, placebo-controlled trial. Lancet. 2026世界杯直播赛程 2015;385:341-50.
16. Blom DJ, Hala T, Bolognese M. A 52-week 观看比赛直播 placebo-controlled trial of evolocumab in hyperlipidemia. N Engl J Med. 2014;370:1809-1819.
17. Koren MJ, Giugliano RP, Raal FJ, et 世界杯直播频道 al. Efficacy and Safety of
世界杯直播频道 观看比赛直播
18. Lopez D. FIFA 2026开球时间 PCSK9: An enigmatic protease. Biochimica et Biophysica Acta. 2008;1781:184-191.
19.
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